NCT03631589Unknown2 期
Treatment of Steroid-resistant Severe Acute Graft-versus-host Disease With Mesenchymal Stem Cells
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- complete and partial response rate
研究概览
简要总结
Steroid-resistant acute graft-versus-host disease (aGVHD) is one of the most severe complications in the setting of allogeneic hematopoietic stem cell transplantation (HSCT), which cannot be significant benefit from the second-line therapies.The mesenchymal stem cells (MSCs) possess extensive immunomodulatory properties and are very promising to rescue the refractory aGVHD.This study aims to assess the efficacy and safety of MSCs for the treatment of the refractory aGVHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Aged <65 years
- •Patients with steroid-resistant severe aGVHD
- •Cardiac: Left ventricular ejection fraction ≥ 50%
- •Adequate renal and hepatic function
- •Performance status: Karnofsky ≥ 70%
排除标准
- •Pregnant or lactating females.
- •Any co-morbidity precluding the administration of MSCs.
研究组 & 干预措施
MSCs treated
Experimental
干预措施: MSCs (Biological)
结局指标
主要结局
complete and partial response rate
时间窗: 1 year
次要结局
- Adverse events that are related to treatment(1 year)
研究者
Jianda Hu
Director of the department of Hematology
Fujian Medical University
研究点 (1)
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